Apparatus and method for anterior intervertebral spinal fixation and fusion

ABSTRACT

A spinal fixation and fusion device that includes a housing with leading deep surface conforming to the posterior aspect of the intervertebral disk and trailing outer surface conforming to the anterior surface of the disk, weight bearing sides and the top and bottom surfaces with plurality of openings enabling ingrowths of bone. The device further includes a shaft running from the center of the deep surface and perpendicular to the deep surface of the housing to the center of the outer surface of the housing and affixed at least to the deep surface of the housing, and a flat metal member threaded onto the shaft with sharp leading edge which upon clockwise or counterclockwise rotation about the axis of the shaft will break the endplate, hook into the vertebra and rigidly secure the vertebra to the entire device preventing separation of the vertebra from the device during spinal motion.

FIELD OF INVENTION

This invention relates to a spinal fusion device. More specifically, the present invention relates to an implant and fixation device used to reconstruct spinal disk space and facilitate fusion across spinal disk apace.

BACKGROUND

Articulations between bony vertebras of human spine frequently deteriorate with age or trauma and become a source of pain. Spinal disk is one of these articulations and with aging process it loses its normal consistency and volume and collapses allowing for abnormal painful motion within the anterior spinal column. Spinal disk is a complex cylindrical weigh-bearing fibrous structure with non-compressible viscous center. Disk articulates with bony vertebra above and below through a large surface area circular interface known as an endplate (FIG. 1). Endplate is a thin (1-3 mm) approximately round 2-4 cm in diameter plate of dense bone and cartilage accounting for majority of the vertebral weight-bearing capacity (FIG. 2).

Surgical treatment of disk disorders frequently require elimination of movement across the abnormal disk. This is accomplished by allowing bone to grow between adjacent vertebra and through the disk space. It is desirable to reconstruct the disk pace to its prior normal height by opening the space previously occupied by the removed disk while retaining normal curvature of the spine determined by the differential height between front and back of the disk (FIG. 3). This is commonly achieved by using inserts which open the space and allow for growth of the bridging bone. The ultimate effectiveness of an implant is based on the following factors: (i) ability to reconstruct and maintain the normal configuration of the vertebral column; (ii) ease of insertion; (iii) facilitation of bony fusion; (iv) restriction of movement across the disk space.

Implants utilized in fusion of a human spine and delivered in a straight trajectory through the front of the spine and into the disk space are well known to those skilled in the art. They vary in shape but possess similar characteristics with upper and lower surfaces conforming to the shape of the vertebral endplates and vertical design aiming to open or reconstruct collapsed disk space. These implants are sufficiently porous or hollow to allow bone to grow through the implant and bridge two vertebras referred to as bone fusion. These implants perform well with vertical loading of the spine or in flexion. They are not able to restrict movement between two vertebra when vertebra are pulled apart or in extension and lateral bending and they provide negligible restriction during sliding motion (translation) and rotation.

Devices which cut into or have protrusions directed into or through the endplate, are also known in the related art. These protrusions penetrate the endplate and potentially create channels for a bone growth yet, do not alter structural properties of the endplate. They also reduce the risk of extrusion of the implant out of the disk space. These protrusions restrict translation or sliding motion but they do not restrict extension and lateral bending. This necessitates additional fixation (immobilization) usually consisting of posterior pedicle screws.

There would be a substantial benefit in an anterior fixation device which would on its own rigidly fixate the spine in all direction of motion.

SUMMARY OF THE INVENTION

Device for reconstruction, fixation and bone fusion through anterior approach to the human spine. This device enables rigid fixation in all planes of motion including extension of the spine, it possesses structural characteristics necessary to reconstruct and maintain disk height, it provides space for bone grafting material and produces a plurality of perforations through endplates above and below to enhance bony fusion.

DETAILED DESCRIPTION

The implant consists of the outer structure or shell which is designed to conform to the disk space, provide openings for bony ingrowths and maintain the disk height by providing adequate structural strength and sufficient weight bearing surface. The shell contains a shaft which runs through its central axis from the back to the front and is fixed to the shell (FIG. 7).

In the preferred embodiment the shell is impacted into the disk space (FIG. 14) using the shell introducer (FIG. 15). Introducer fits tightly to the sides of the shell but is open in the center to allow for blades (FIG. 13).

Once the shell is placed in a correct position, individual blades (FIG. 11) are selected, mounted onto the introducer (FIG. 15) and threaded onto the shaft in horizontal orientation (FIG. 16). The blade is placed as deep as it can go and then rotated into vertical orientation breaking the endplate and hooking into the vertebra (FIG. 17). Blades alternate between clockwise and counterclockwise orientation. Variable size blades can be selected to better approximate configuration of the disk space.

Once all the blades are engaged, a tightening nut is applied.

In an alternative embodiment alternating clockwise and counterclockwise blades (FIG. 18) are pre-loaded onto the shaft and inside the housing (FIG. 19). With the help of an introducer (FIG. 20) blades are rotated sequentially going from superficial to deep.

In another embodiment the housing expands horizontally and contains two shafts which separate from each other upon expansion of the housing. In the initial collapsed configuration, pre-loaded clockwise and counterclockwise blades threaded on different shafts imbricate between each other. After the cage is expanded, blades are pulled apart.

In another embodiment body of the blade is configured as an oval so that the disk space is expended as a blade is rotated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 Anterior view of the lumbar spine demonstrating vertebra (1) alternating with disk (2).

FIG. 2 Anterior view of the vertically sliced lumbar spine demonstrating internal composition of the vertebra with dense endplate (3) and softer inner part (4).

FIG. 3 Lateral (side) view of the vertebral column demonstrating normal curvature (lordosis) of the lumbar spine.

FIG. 4 Lateral (side) view of the preferred embodiment of the housing with front opening (8) and back wall (9). Please note the central shaft (10) fixed to the back wall.

FIG. 5 Anterior (front) view through the front opening (8) of the housing with lateral weight bearing walls (5), top (6) and bottom (7) openings. Note central shaft (10).

FIG. 6 Superior (top) view through the top opening (6) of the housing. Note central shaft (10).

FIG. 7 Perspective view of the housing.

FIG. 8 Front view of the preferred embodiment of the clockwise blade. The cutting extensions (11) have sharp ends which cut through the endplate and into the cancellous bone. The central opening (12) fits over the shaft of the housing. The control nut (13) is used to handle the blade. The body of the blade (14) provides additional central weight bearing support against vertebral endplates.

FIG. 9 Front view of the preferred embodiment of the counterclockwise blade.

FIG. 10 Top view of the counterclockwise blade

FIG. 11 Perspective view of the counterclockwise blade

FIG. 12 Preferred embodiment of the insertion instrument for the housing. The prongs (15) fit inside the lateral walls of the housing (5) but clear central opening (16) occupied by the blades.

FIG. 13 Preferred method of housing placement into collapsed disk space (2).

FIG. 14 Housing inside expended disk space.

FIG. 15 Preferred embodiment of the blade holding instrument. Note the receptacle for the control nut and central opening for the shaft.

FIG. 15 Blade introduced horizontally into the housing using blade introducer

FIG. 17 Blade rotated vertically piercing vertebral endplates and hooking into vertebra

FIG. 18 Alternative embodiment of the blade. These blades are preloaded into the housing prior to placement into the disk space.

FIG. 19 Transparent housing and central shaft with pre-loaded blades showing front two blades rotated into final vertical position.

FIG. 20 Blade rotating tool fits into control opening of clockwise and counterclockwise blades with rotating tool engaged first three blades. 

1. A device utilized in reconstruction and fusion of human spine providing direct rigid fixation of anterior spinal column in flexion, extension and rotation, said devise comprising a housing with leading deep surface conforming to the posterior aspect of the intervertebral disk and trailing outer surface conforming to the anterior surface of the disk, weight bearing sides and the top and bottom surfaces with plurality of openings enabling ingrowths of bone; and a shaft running from the center of the deep surface and perpendicular to the deep surface of the housing to the center of the outer surface of the housing and affixed at least to the deep surface of the housing; and a flat metal member threaded onto the shaft with sharp leading edge which upon clockwise or counterclockwise rotation about the axis of the shaft will break the endplate, hook into the vertebra and rigidly secure the vertebra to the entire device preventing separation of the vertebra from the device during spinal motion.
 2. The housing used in the device for spinal fixation as claimed in claim 1 wherein said housing is configured in the shape of a box, cylinder or other geometric shape including configurations with height of the deep surface smaller then the height of the anterior surface, said shapes conforming to the shape of the spinal disk apace.
 3. The housing as claimed in claim 2 wherein said housing is expandable at least in part in vertical and horizontal directions.
 4. The housing as claimed in claim 2 wherein said housing comprises at least one of the following materials: metal, plastic, ceramic, graphite, coral or human bone products.
 5. The housing as claimed in claim 2 wherein said housing is absorbable.
 6. The housing as claimed in claim 2 wherein said housing is formed at least in part of a porous material.
 7. The shaft used in the device for spinal fixation as claimed in claim 1 wherein a plurality of said shafts serve as axis of rotation which can be fixed or can move away from each other when the housing is expended at least in part in vertical and horizontal directions.
 8. The member used in the device for spinal fixation as claimed in claim 1 wherein said member possesses two opposing leading edges which hook into two adjacent vertebra fixing both vertebra in relation to each other and to the entire device.
 9. Plurality of members as claimed in claim 7 wherein members vary in size to accommodate for a tapered configuration of the housing.
 10. Plurality of members as claimed in claim 7 wherein members alternate in clockwise and counterclockwise orientation.
 11. A means by which plurality of members claimed in claim 7 is individually introduced into the housing and onto the shaft and rotated from horizontal into vertical orientation.
 12. A means by which plurality of members claimed in claim 7 are pre-loaded onto the shaft and into the housing, said members rotated individually or as a group from within the housing while inside the disk space.
 13. A means by which plurality of members claimed in claim 7 are locked in the final engaged position preventing dislodging from vertebra. 